BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 16989986 · Received May 23, 2023

    Report

    Report Number
    9616656-2023-00510
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 2, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2152813. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. DEVICE MANUFACTURE DATE: 01-JUN-2022. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES FROM LOTS 2152813 AND AN UNSPECIFIED LOT HAD NO INSULIN FLOW DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS. STATED, ITS HAPPENED WITH MORE THAN ONE BOX BUT SHE DOES NOT HAVE LOT NUMBERS STATED, ALMOST HALF THE BOX WAS AFFECTED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES FROM LOTS 2152813 AND AN UNSPECIFIED LOT HAD NO INSULIN FLOW DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS STATED, ITS HAPPENED WITH MORE THAN ONE BOX BUT SHE DOES NOT HAVE LOT NUMBERS STATED, ALMOST HALF THE BOX WAS AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849990 BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown